Postmarketing survey results of T.R.U.E. TEST, a new allergen patch test.
BACKGROUND
T.R.U.E. TEST, (Thin-layer Rapid Use Epicutaneous Test; Glaxo Dermatology, Division of Glaxo Wellcome Inc, Research Triangle Park, NC) an allergen patch test used in the diagnosis of contact dermatitis, was first introduced to the United States market on January 16, 1995. A voluntary postmarketing survey of its use during the initial 19.5 months has been conducted.


OBJECTIVE
The survey was conducted to provide information on the incidence of positive reactions to the specific allergens included in the panel as well as to evaluate test performance and safety.


METHODS
Data collection forms were included with each initial order of T.R.U.E. TEST purchased by dermatologists and other physicians. Data for a total of 3,209 patients were analyzed for incidence of dermatitis by body site, reaction frequency to test allergens, physician interpretation of clinical relevance, and adverse events.


RESULTS
Allergens with the highest reaction rates included nickel sulfate (17.8%), Quaternium-15 (10.6%), thimerosal (9.4%), and formaldehyde (8.7%). These figures were similar to those obtained in the North American clinical trials used to support the US market approval of T.R.U.E. TEST. Itching/burning sensation and excited skin were the most frequent adverse events recorded, each reported in less than 2% of patients tested.


CONCLUSIONS
T.R.U.E. TEST provides a standardized, convenient, reliable, and safe method of assessing patients with contact dermatitis.
Prue
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Glaxo Dermatology, Division of Glaxo Wellcome Inc, Glaxo Wellcome Inc, Research Triangle Park, NC 27709, USA.
Martinson
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McAnally
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Stagner
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WC
D000293:Adolescent; D000328:Adult; D000485:Allergens; D017449:Dermatitis, Allergic Contact / Q000175:diagnosis*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010328:Patch Tests / Q000009:adverse effects; D011358:Product Surveillance, Postmarketing
D000485:Allergens